DCT

1:20-cv-01784

Jackson MD v. SeaSpine Holdings Corp

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Key Events
Amended Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:20-cv-01784, D. Del., 04/02/2024
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendant SeaSpine is a Delaware corporation.
  • Core Dispute: Plaintiff alleges that Defendant’s spinal implant systems, primarily the Mariner, Malibu, and NewPort product lines, infringe twelve patents related to polyaxial bone screw and spinal fixation technology.
  • Technical Context: The technology involves surgical implants used in spinal fusion procedures to stabilize vertebrae, a large and technically sophisticated segment of the medical device market.
  • Key Procedural History: The complaint alleges that Plaintiff provided Defendant with actual notice of infringement of certain patents-in-suit as early as October 2017, followed by licensing discussions in 2018 and 2020 which did not result in an agreement; these allegations form the basis for claims of willful infringement.

Case Timeline

Date Event
2003-04-09 Priority Date for '753 and '777 Patents
2003-05-22 Priority Date for '923 and '667 Patents
2004-11-23 Priority Date for '143 and '301 Patents
2005-05-27 Priority Date for '273 Patent
2005-07-01 Malibu System FDA Approval (approx.)
2007-10-30 Priority Date for '740, '445, and '292 Patents
2008-05-27 '923 Patent Issued
2009-01-01 NewPort System FDA Approval (approx.)
2012-01-10 Priority Date for '646 and '873 Patents
2013-09-24 '753 Patent Issued
2016-11-01 Mariner System FDA Approval (approx.)
2017-01-01 Mariner System Full Commercial Launch (approx.)
2017-05-30 '143 Patent Issued
2017-10-25 Plaintiff alleges providing actual notice to Defendant re: '753 Patent
2017-11-07 '292 Patent Issued
2019-05-07 '740 Patent Issued
2020-02-18 '445 Patent Issued
2020-03-17 '667 Patent Issued
2020-07-28 '273 Patent Issued
2021-03-23 '777 Patent Issued
2021-09-28 '646 Patent Issued
2022-08-02 '873 Patent Issued
2023-07-25 '301 Patent Issued
2024-04-02 Third Amended Complaint Filed

II. Technology and Patent(s)-in-Suit Analysis

U.S. Patent No. 7,377,923 - Variable Angle Spinal Screw Assembly

  • Patent Identification: U.S. Patent No. 7,377,923, titled "Variable Angle Spinal Screw Assembly," issued on May 27, 2008.

The Invention Explained

  • Problem Addressed: The patent's background describes the difficulty surgeons face in positioning spinal fixation rods within the heads of bone screws due to the complex curvature of the spine (Compl. ¶11; ’923 Patent, col. 1:12-32). Fixed-angle screws require perfect alignment, which is often surgically challenging or impossible.
  • The Patented Solution: The invention is a polyaxial, or "variable angle," pedicle screw assembly where the screw head can pivot relative to the bone-implanted shank ('923 Patent, Abstract). This is achieved by capturing the spherical head of the screw shank within a corresponding socket in the body member, allowing for multi-directional angulation before being locked into a final position by a fixation rod and locking cap ('923 Patent, col. 2:40-58).
  • Technical Importance: This polyaxial capability grants surgeons greater intra-operative flexibility to connect spinal rods to anchors, potentially simplifying the procedure, reducing operating time, and accommodating patient-specific anatomy ('923 Patent, col. 1:47-51).

Key Claims at a Glance

  • The complaint asserts at least independent claim 4 (Compl. ¶52).
  • The essential elements of Claim 4 include:
    • A pedicle screw having a head portion and a threaded shaft portion.
    • A body member for receiving the head portion, defining a channel for a fixation rod and having an aperture for the shaft portion to extend through.
    • A bushing disposed within the body member adjacent to the screw head, defining a seat for the fixation rod.
    • A locking cap to bear against the fixation rod to secure it within the assembly.
  • The complaint reserves the right to assert additional claims (Compl. ¶53).

U.S. Patent No. 10,588,667 - Top and Bottom Loadable Bone Screw Assembly with Direct Pivotal Engagement Between Shank Head and Receiver

  • Patent Identification: U.S. Patent No. 10,588,667, titled "Top and Bottom Loadable Bone Screw Assembly with Direct Pivotal Engagement Between Shank Head and Receiver," issued on March 17, 2020.

The Invention Explained

  • Problem Addressed: The patent addresses challenges related to the assembly and strength of polyaxial screw components, particularly how the screw shank is loaded into and retained by the receiver head (’667 Patent, col. 1:26-38).
  • The Patented Solution: The invention describes a bone screw assembly where the shank can be loaded into the receiver from either the top or the bottom. It features a specific "split ring" or collet-type bushing that resiliently expands to allow the shank head to pass through and then contracts to capture it, creating a direct pivotal engagement between the shank head and the receiver (’667 Patent, col. 2:5-20, Fig. 1).
  • Technical Importance: This design potentially simplifies the manufacturing and surgical assembly process while providing a strong, reliable polyaxial mechanism that can be locked securely by a fixation rod and closure (’667 Patent, col. 2:42-50).

Key Claims at a Glance

  • The complaint asserts at least independent claims 1 and 7 (Compl. ¶63).
  • The essential elements of Claim 1 include:
    • A screw with a shank body, a head, and a tool engagement surface.
    • A body member for receiving the head, defining a channel for a fixation rod.
    • A bushing positionable within the body member, having a bore to receive the screw head.
    • The bushing and screw head being bottom loadable into the body member.
  • The essential elements of Claim 7 are similar to claim 1 but are directed to a method of using the assembly.
  • The complaint reserves the right to assert additional claims (Compl. ¶64).

U.S. Patent No. 8,540,753 - Polyaxial Bone Screw With Uploaded Threaded Shank and Method of Assembly and Use

  • Patent Identification: U.S. Patent No. 8,540,753, "Polyaxial Bone Screw With Uploaded Threaded Shank and Method of Assembly and Use," issued September 24, 2013.
  • Technology Synopsis: This patent describes a polyaxial screw where the shank is "uploaded" (i.e., inserted from the bottom) into the receiver head. The capture mechanism relies on mating threads between the shank's capture structure and the head's inner surface, which are disengaged after assembly to allow for free pivotal motion (’753 Patent, col. 2:5-26).
  • Asserted Claims: At least claims 1 and 14 are asserted (Compl. ¶74).
  • Accused Features: The Mariner screw products are accused of infringement (Compl. ¶73).

U.S. Patent No. 10,278,740 - Pivotal Bone Anchor Assembly with Cannulated Shank Threaded Capture Connection and Compression Insert

  • Patent Identification: U.S. Patent No. 10,278,740, "Pivotal Bone Anchor Assembly with Cannulated Shank Threaded Capture Connection and Compression Insert," issued May 7, 2019.
  • Technology Synopsis: The technology relates to a polyaxial bone anchor assembly featuring a cannulated (hollow) shank for guided placement. It includes a threaded connection for capturing the shank within the receiver and a separate compression insert that facilitates locking the assembly's angle (’740 Patent, Abstract).
  • Asserted Claims: At least claims 1, 2, 3, and 4 are asserted (Compl. ¶85).
  • Accused Features: The Mariner screw products are accused of infringement (Compl. ¶84).

U.S. Patent No. 10,561,445 - Pivotal Bone Anchor Assembly with Cannulated Shank Threaded Capture Connection and Compression Insert

  • Patent Identification: U.S. Patent No. 10,561,445, "Pivotal Bone Anchor Assembly with Cannulated Shank Threaded Capture Connection and Compression Insert," issued February 18, 2020.
  • Technology Synopsis: This patent is related to the '740 patent and similarly describes a pivotal bone anchor with a cannulated shank, threaded capture connection, and a compression insert. The claims focus on the specific mechanical interactions between the insert, the shank, and the receiver that allow the assembly's angle to be set and locked (’445 Patent, Abstract).
  • Asserted Claims: At least claims 1, 5, 6, 7, and 27 are asserted (Compl. ¶96).
  • Accused Features: The Mariner screw products are accused of infringement (Compl. ¶95).

U.S. Patent No. 10,952,777 - Pivotal Bone Screw Assembly with Receiver Having Threaded Open Channel and Lower Opening

  • Patent Identification: U.S. Patent No. 10,952,777, "Pivotal Bone Screw Assembly with Receiver Having Threaded Open Channel and Lower Opening," issued March 23, 2021.
  • Technology Synopsis: This invention describes a polyaxial screw where the shank is loaded through a lower opening in the receiver and captured via a threaded connection. The receiver itself has a threaded open channel for receiving a closure top to secure a fixation rod (’777 Patent, Abstract).
  • Asserted Claims: At least claims 1 and 10 are asserted (Compl. ¶107).
  • Accused Features: The Mariner screw products are accused of infringement (Compl. ¶106).

U.S. Patent No. 9,662,143 - Dynamic Fixation Assemblies with Inner Core and Outer Coil-Like Member

  • Patent Identification: U.S. Patent No. 9,662,143, "Dynamic Fixation Assemblies with Inner Core and Outer Coil-Like Member," issued May 30, 2017.
  • Technology Synopsis: This patent describes a flexible spinal fixation assembly, rather than a rigid rod. It consists of an inner core and a flexible outer "coil-like" member, designed to allow for "dynamic, protected motion of the spine" instead of rigid fusion, while still providing stabilization (’143 Patent, col. 2:50-55).
  • Asserted Claims: At least claims 1, 2, and 7 are asserted (Compl. ¶117).
  • Accused Features: The Mariner screw products, when used as part of a fixation system, are accused of infringement (Compl. ¶116).

U.S. Patent No. 11,129,646 - Medical Implant Threaded Plug Having a Start Structure with Symmetrically Shaped Concave and Convex Leading Surfaces

  • Patent Identification: U.S. Patent No. 11,129,646, "Medical Implant Threaded Plug Having a Start Structure with Symmetrically Shaped Concave and Convex Leading Surfaces," issued September 28, 2021.
  • Technology Synopsis: This invention focuses on the design of the threaded plug (or closure cap). It claims a specific "start structure" on the thread with concave and convex surfaces, designed to facilitate easier, non-cross-threaded engagement with the receiver arms of the bone screw (’646 Patent, Abstract).
  • Asserted Claims: At least claim 1 is asserted (Compl. ¶126).
  • Accused Features: The Mariner screw products are accused of infringement (Compl. ¶125).

U.S. Patent No. 11,399,873 - Medical Implant Threaded Plug Having a Start Structure

  • Patent Identification: U.S. Patent No. 11,399,873, "Medical Implant Threaded Plug Having a Start Structure," issued August 2, 2022.
  • Technology Synopsis: Closely related to the '646 patent, this invention also details a specific geometry for the start of the thread on a closure plug. The claimed structure is designed to ensure proper alignment and engagement with the receiver, preventing cross-threading during surgical installation (’873 Patent, Abstract).
  • Asserted Claims: At least claim 1 is asserted (Compl. ¶137).
  • Accused Features: The Mariner screw products are accused of infringement (Compl. ¶136).

U.S. Patent No. 11,707,301 - Threaded Closure for Bone Anchor Receivers with Parallel Planar Outer Surfaces and Methods of Use

  • Patent Identification: U.S. Patent No. 11,707,301, "Threaded Closure for Bone Anchor Receivers with Parallel Planar Outer Surfaces and Methods of Use," issued July 25, 2023.
  • Technology Synopsis: This patent describes a method of securing a rod using a bone anchor that has a receiver with parallel outer surfaces. The method involves placing the rod and then engaging a threaded closure with the receiver to lock the rod in place, focusing on the procedural aspects of using such an implant (’301 Patent, Abstract).
  • Asserted Claims: At least claim 7 (a method claim) is asserted (Compl. ¶148).
  • Accused Features: The use of the Mariner screw products by surgeons is accused of infringing the claimed method (Compl. ¶147).

U.S. Patent No. 10,722,273 - Bone Anchor Assembly with Twist-In-Place Pressure Insert

  • Patent Identification: U.S. Patent No. 10,722,273, "Bone Anchor Assembly with Twist-In-Place Pressure Insert," issued July 28, 2020.
  • Technology Synopsis: The invention describes a polyaxial screw with a "twist-in-place pressure insert." This insert can be used to preliminarily lock the angle of the shank relative to the receiver before the main fixation rod is fully secured, giving the surgeon independent control over angulation (’273 Patent, col. 2:36-44).
  • Asserted Claims: At least claims 1 and 39 are asserted (Compl. ¶157).
  • Accused Features: The Mariner screw products are accused of infringement (Compl. ¶156).

U.S. Patent No. 9,808,292 - Cannulated Polyaxial Screw

  • Patent Identification: U.S. Patent No. 9,808,292, "Cannulated Polyaxial Screw," issued November 7, 2017.
  • Technology Synopsis: This patent details a cannulated polyaxial screw assembly where the shank is captured within the receiver by a retaining ring. The capture mechanism involves passing splines on the shank through channels in the ring, then rotating the shank so the splines engage capture recesses in the ring (’292 Patent, Abstract).
  • Asserted Claims: At least claim 1 is asserted (Compl. ¶168).
  • Accused Features: The Mariner, Malibu, and NewPort screw products are accused of infringement (Compl. ¶167).

III. The Accused Instrumentality

Product Identification

  • The accused products are Defendant’s SeaSpine Mariner, Malibu, and NewPort systems, which are pedicle screw systems used for spinal fixation (Compl. ¶¶ 26, 47, 49). The complaint’s detailed infringement allegations focus primarily on the Mariner system.

Functionality and Market Context

  • The complaint alleges the Mariner system is a "premier pedicle screw system" central to SeaSpine's development pipeline (Compl. ¶¶ 27, 35). Its key features are described as "Modular Threaded Technology" and "Motion Limiting Technology" (Compl. ¶35). The complaint provides visuals from a marketing video that depict this functionality, such as an image showing the threaded upper end of the screw shank (blue) and the internally threaded head (silver) (Compl. ¶38, p. 12). Another visual illustrates the "Threaded Modular Technology," where the shank is loaded into the head from the bottom in an upward direction (Compl. ¶39, p. 13). The system is alleged to allow for significant angulation of the shank relative to the head, described by SeaSpine as "60° of Angulation" (Compl. ¶40, p. 13). The Malibu and NewPort systems are also described as polyaxial screw systems, with cannulated shank options available (Compl. ¶¶ 48-49).

IV. Analysis of Infringement Allegations

The complaint references but does not attach claim chart exhibits detailing the infringement allegations (Compl. ¶¶ 52, 63). The following narrative summarizes the infringement theory for the lead patents based on the complaint's description of the accused products.

  • '923 Patent Infringement Allegations: The complaint alleges that the Mariner screw products constitute a "variable angle spinal screw assembly" as recited in claim 4 (Compl. ¶52). The Mariner system's separate shank and head components, which are assembled to allow for polyaxial movement before being locked by a fixation rod and closure top, are alleged to meet the claim limitations (Compl. ¶¶ 38-46, 53). For example, a video screenshot shows the process of threading the appropriate heads onto the previously implanted shanks, which suggests the modular components form the claimed "assembly" during the surgical procedure (Compl. ¶43, p. 15). The various available head options and the adjustable angular positioning correspond to the "variable angle" nature of the invention (Compl. ¶¶ 36, 40).
  • '667 Patent Infringement Allegations: The complaint alleges the Mariner products comprise a "spinal screw assembly" as set forth in claims 1 and 7 (Compl. ¶63). The infringement theory appears to map the Mariner system's "Threaded Modular Technology," where the shank is loaded from the bottom of the receiver, to the "bottom loadable" limitation of the claims (Compl. ¶¶ 39, 63). The interaction between the threaded shank head and the threaded receiver is alleged to constitute the claimed "direct pivotal engagement" once assembled (Compl. ¶¶ 38, 63).
  • Identified Points of Contention:
    • Scope Questions: A central question may be whether the term "assembly" in the claims requires the components to be pre-assembled before implantation. The complaint describes the Mariner system's modularity, where heads are attached to shanks after the shanks are implanted in the vertebrae (Compl. ¶¶ 42-43). This raises the question of whether this surgical technique of combining components in situ meets the definition of the claimed "assembly."
    • Technical Questions: For the '667 Patent, a potential point of contention could be the meaning of "direct pivotal engagement between shank head and receiver." The analysis may focus on whether the threaded connection alleged in the Mariner product (Compl. ¶38) functions in the same way as the engagement described in the patent, which may rely on a distinct capture mechanism like a collet or ring.

V. Key Claim Terms for Construction

  • The Term: "bushing" (from '923 Patent, Claim 4)

  • Context and Importance: Claim 4 requires a "bushing disposed within said body member adjacent to said head portion." The nature and function of this "bushing" will be critical. The infringement reading may depend on whether one of the modular components of the Mariner system, such as an insert or the shank head itself when seated, can be construed as a "bushing."

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The patent may describe the function of the bushing in general terms, such as providing a seat for the fixation rod or distributing force, which could support an argument that any component performing this function qualifies (’923 Patent, col. 4:50-55).
    • Evidence for a Narrower Interpretation: The patent's detailed description and figures may depict the "bushing" as a separate, distinct component with a specific structure (e.g., a slotted skirt or tapered surfaces) that is different from the other parts of the assembly, which could support a narrower definition that does not read on the accused product's components (’923 Patent, Fig. 5, col. 5:35-45).

  • The Term: "bottom loadable" (from '667 Patent, Claim 1)

  • Context and Importance: Claim 1 requires the screw and bushing to be "bottom loadable into said body member." The infringement theory for the Mariner system relies on its "Threaded Modular Technology" being "bottom loaded" (Compl. ¶¶ 39, 63). The case may turn on whether "bottom loadable" implies a simple insertion versus a threaded engagement.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification may use "loadable" broadly to refer to any method of insertion from the bottom, including threading. The summary of the invention might describe the benefit as simply enabling bottom-up assembly without limiting the specific mechanism (’667 Patent, col. 2:5-15).
    • Evidence for a Narrower Interpretation: The figures and embodiments may exclusively show a snap-fit or drop-in loading mechanism where a resilient component expands and contracts to capture the shank head. This could support an argument that "loadable" in the context of the patent means something other than a threaded screw-in assembly process (’667 Patent, col. 6:40-55).

VI. Other Allegations

  • Indirect Infringement: The complaint alleges induced infringement against SeaSpine for encouraging surgeons to use the accused products in an infringing manner. This is based on providing instructions, surgical technique guides, and tools that allegedly direct users to perform the claimed steps of assembling and implanting the devices (Compl. ¶¶ 56, 67, Ex. 30). Contributory infringement is alleged based on the sale of components in surgical trays that are designed to work together and have no substantial non-infringing use (Compl. ¶¶ 57, 68).
  • Willful Infringement: The complaint alleges willful infringement based on pre-suit knowledge. Plaintiff alleges it provided specific notice to SeaSpine's CEO regarding U.S. Patent No. 8,540,753 on October 25, 2017, and engaged in licensing discussions regarding the '923, '292, and '753 patents during the summer of 2018 (Compl. ¶¶ 32, 77). Knowledge of other patents is alleged based on subsequent communications and the filing of prior versions of the complaint in this litigation (Compl. ¶¶ 66, 88, 99, etc.).

VII. Analyst’s Conclusion: Key Questions for the Case

This dispute appears to center on the intersection of established spinal implant concepts and specific, patented mechanical improvements. The key questions for the court will likely be:

  • A core issue will be one of claim scope and timing: Can the term "assembly," as used in several patents, be construed to cover a modular system where key components like the shank and receiver are combined by a surgeon in situ during a procedure, or does the term require a pre-assembled unit?
  • A second critical issue will be one of technical mechanism: Does the "threaded modular technology" of the accused Mariner system, which relies on threaded engagement for both assembly and pivotal motion, operate in the same way as the specific capture and engagement mechanisms (e.g., bushings, split rings) required by the patent claims?
  • A key question for damages will be one of intent: Given the complaint's detailed allegations of specific pre-suit notice and failed licensing discussions dating back to 2017, the court will need to evaluate whether Defendant’s continued sales of the accused products constitute willful infringement warranting enhanced damages.